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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS "MOTOR BIOCONSOLE EXT.DR MOTOR,54" CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS "MOTOR BIOCONSOLE EXT.DR MOTOR,54" CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 95120-003
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The report that the motor was not operating as expected was confirmed during service. Analysis found that the motor did not start in all positions and when it did start, the speed rose to maximum levels. The depot service technician found no issues when the resistance measurements of each conductor in the cable was performed. The suspected root cause of the issue is one of the phases in the motor not functioning properly; however, the analysis and investigation could not identify and confirm a specific root cause. Complaints received from january 2011 to september 2016 for 540t external motor drives were reviewed. There were no trends identified for this issue. Medtronic will continue to monitor for similar events.
 
Event Description
Medtronic received information that during the first use of this new external drive motor it did not operate as expected. The user stated that the revolutions per minute (rpm) were "shifting". The drive motor was replaced and there was no adverse patient effect. The motor was returned to medtronic for analysis.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during the first use of this new external motor drive instrument, it did not operate as expected due to the rpm (revolutions per minute) were shifting. The instrument was changed out and there was no adverse patient effect. The instrument will be returned for service.
 
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Brand Name"MOTOR BIOCONSOLE EXT.DR MOTOR,54"
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer (Section G)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer Contact
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key5993699
MDR Text Key101854957
Report Number2184009-2016-00017
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K941921
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number95120-003
Device Catalogue Number95120-003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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